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Abstract:

A drug delivery device 10 has a support structure 20 and a medicine-laden
member 100 affixed or otherwise attached to the support structure 20. The
device 10 is sized to fit into the mouth and upon exposing the
medicine-laden member 100 to saliva, medicaments 101 are released into
the mouth. The drug delivery device 10 permits a new method of medication
delivery. The method of oral transmucosal drug delivery has the steps of
providing a drug delivery device 10 that fits into the mouth, the device
10 having a medicine-laden member 100; wearing the drug delivery device
10; activating release of medicine 101 by contact with saliva; and
transmitting the released medicine 101 transmucosally to the bloodstream.

Claims:

1. A drug delivery device comprises: a support structure; a
medicine-laden member affixed or otherwise attached to the support
structure; and wherein the device is sized to fit into the mouth and upon
exposing the medicine-laden member to saliva, medicaments are released
into the mouth.

2. The drug delivery device of claim 1 wherein the device is worn in the
mouth over the teeth and along the gums of a wearer, the device and the
support structure is a flexible open-support structure, the flexible
open-support structure having two opposing bases, an inner base and an
outer base, each base extends along the length of the device and has a
curvature to fit over the teeth and along the gums of a wearer of the
device, the inner base fits between the teeth and the tongue while the
outer base fits between the teeth and cheek and lips region of the mouth,
a plurality of arch-shaped ribs extend from the inner base to the outer
base joining the two bases to form the flexible open-support structure;
and wherein the support structure has a means for receiving and holding
the medicine-laden member for delivering a medicament transmucosally
wherein the medicine-laden member is wetted by the production of saliva
allowing the medicament to migrate into the mouth.

3. The drug delivery device of claim 2 wherein the flexible open-support
structure has a connecting spine longitudinally extending between each
arch rib connecting each rib along the length of the support structure.

4. The drug delivery device of claim 2 wherein the means for holding the
medicine-laden member is a channel extending along the length of the
support structure.

5. The drug delivery device of claim 4 wherein the inner base has a
recessed groove on a surface of the inner base extending along the length
of the support structure, the groove forming the channel.

6. The drug delivery device of claim 5 wherein each inner base and outer
base has a curved inner surface extending along the length of the
structure, the combination of curved inner surfaces forms a flexible
channel that on wearing grips onto the outer surface of the teeth or
gums.

7. The drug delivery device of claim 1 wherein the support structure is
made of a flexible plastic or elastomer.

8. The drug delivery device of claim 2 wherein the arched ribs are shaped
to form a flexible spring-like enclosure of the inner base and opposing
outer base, wherein upon inserting over the teeth, the bases open keeping
the inner base and outer base in contact with the teeth and along the
gums.

9. The drug delivery device of claim 1 wherein the medicine-laden member
upon being wetted by saliva releases medicaments that flow from the
support structure under the movement of the tongue of the wearer.

10. The drug delivery device of claim 2 wherein the plurality of arched
ribs are positioned along rearward portions of the base structure which
overlays the molars when worn.

11. The drug delivery device of claim 10 wherein no arched ribs are
located over regions which overlay the front teeth when worn.

12. The drug delivery device of claim 11 wherein the inner and outer
bases are concealed by the mouth and cheeks when the device is worn.

13. The drug delivery device of claim 1 wherein the medicine-laden member
for attachment in the support structure is made in the shape of a cord or
string impregnated with a medicament.

14. The drug delivery device of claim 12 wherein the medicine-laden
member is made of a string or cord, the material of the string or cord
being polystyrene or other natural or synthetic material suitable for
being impregnated with a medicament.

15. The drug delivery device of claim 13 wherein the medicament
impregnated into the cord is releasable when exposed to saliva.

16. The drug delivery device of claim 15 wherein the medicine is released
when worn under the tongue region and delivered to the sublingual area.

17. The drug delivery device of claim 1 where the medicine is any drug
needing to be delivered in a controlled manner.

18. A method of oral transmucosal drug delivery comprises the steps of:
providing a drug delivery device that fits into the mouth, the device
having a medicine-laden member; wearing the drug delivery device;
activating release of medicine by contact with saliva; transmitting the
released medicine transmucosally to the blood stream.

19. The method of oral transmucosal drug delivery of claim 18 wherein the
medicine-laden member is impregnated with a medicament including, but not
limited to protein based drugs such as insulin and its analogues;
anti-angina drugs such as the nitrates; hormones such as the estrogens,
androgens and progestogens; pain controlling drugs such as the opiates,
NSAIDs; nicotine replacement drugs; vaccines of viral or bacterial
products; and any drug that needs repeated doses during the day.

20. The drug delivery device of claim 1 wherein the medicine-laden member
is impregnated with a medicament including, but not limited to protein
based drugs such as insulin and its analogues; anti-angina drugs such as
the nitrates; hormones such as the estrogens, androgens and progestogens;
pain controlling drugs such as the opiates, NSAIDs; nicotine replacement
drugs; vaccines of viral or bacterial products; and any drug that needs
repeated doses during the day.

Description:

TECHNICAL FIELD

[0001] This invention relates to an oral transmucosal drug delivery device
that can be worn any time, concealed from view, preferably over the lower
teeth and gums and provided with a removable medicine-laden member to
deliver medicine directly into the blood stream of a patient through
mucous membranes while bypassing the stomach and gastrointestinal tract.

BACKGROUND OF THE INVENTION

[0002] The most common way for administering medicine to patients is the
oral route. While this route is convenient, there are some problems
associated with it. For example, there is delay in absorption, and
potential for side effects. Also, many drugs are absorbed abruptly, the
blood levels rise quickly and just as quickly, the drug levels drop. This
would lead to administering most drugs in multiple dosing to get some
stability in the blood level. Sometimes this problem is circumvented by
slowing the release of the drugs from the pills, in the stomach or
intestines (extended or slow-release formulations).

[0003] Many other drugs are not suitable for the oral form as they may be
rendered ineffective by the enzymes and the other components of the
gastrointestinal juices. This is the case with all protein substances.
Examples are Insulin and allergy shot antigens. These agents are
therefore usually administered parenterally (by injection route).

[0004] The present invention provides a unique solution that will enable a
variety of medicines to be self-administered transmucosally using a
unique delivery system and device as described as follows. By formulating
suitable carrier member(s) that will release drug(s) in a controlled,
slow manner and then working along with higher or lower concentrations,
any drug can be administered effectively. The current invention can make
any drug available for absorption in a controlled manner, throughout the
day and night. By making such agents available for rapid and direct
absorption through the mucous membrane of the mouth, one can make all
such drugs available for convenient administration. Thus, the avoidance
of the pain as well as the logistics and expense of parenteral
administration are special benefits of this new means of drug delivery.

SUMMARY OF THE INVENTION

[0005] A drug delivery device has a support structure and a medicine-laden
member affixed or otherwise attached to the support structure. The device
is sized to fit into the mouth and upon exposing the medicine-laden
member to saliva, medicaments are released into the mouth. The drug
delivery device permits a new method of medication delivery. The method
of oral transmucosal drug delivery has the steps of providing a drug
delivery device that fits into the mouth, the device having a
medicine-laden member; wearing the drug delivery device; activating
release of medicine by contact with saliva; and transmitting the released
medicine to mucous membrane of the mouth.

[0006] The device is worn in the mouth preferably over the teeth and along
the gums of a wearer. The device and more particularly, the support
structure is a flexible open-support structure. The flexible open-support
structure has two opposing bases, an inner base and an outer base. Each
base extends along the length of the device and has a curvature to fit
over the teeth and along the gums of a wearer of the device. The inner
base fits between the teeth and the tongue while the outer base fits
between the teeth and cheek and lips region of the mouth. A plurality of
arch-shaped ribs extends from the inner base to the outer base joining
the two bases to form the flexible open-support structure. The support
structure has a means for receiving and holding the medicine-laden member
for delivering a medicament transmucosally. The medicine-laden member is
wetted by the production of saliva allowing the medicament to migrate
into the mouth under the tongue where it is absorbed into the mucous
membrane and transmitted into the bloodstream.

[0007] The flexible open-support structure has a connecting spine
longitudinally extending between each arch rib connecting each rib along
the length of the support structure.

[0008] The means for holding the medicine-laden member is a channel or
groove extending along the length of the support structure. In a
preferred embodiment the inner base has a recessed groove on a surface of
the inner base extending along the length of the support structure, the
groove forming the channel. In an alternative embodiment a flange is
provided on the lower portion of the inner base which forms a groove or
recess to hold the medicine-laden member.

[0009] Each inner base and outer base has a curved inner surface extending
along the length of the structure, the combination of curved inner
surfaces forms a flexible channel that on wearing, grips onto the outer
surface of the teeth or gums. The support structure is preferably made of
a flexible plastic or elastomer. The arched ribs are shaped to form a
flexible spring-like enclosure of the inner base and opposing outer base,
wherein upon inserting over the teeth, the bases open keeping the inner
base and outer base in contact with the teeth and along the gums.

[0010] The plurality of arched ribs are positioned along rearward portions
of the base structure which overlays the molars when worn. No arched ribs
are located over regions which overlay the front teeth when worn; thus
the inner and outer bases are concealed by the mouth and cheeks when the
device is worn.

[0011] The medicine-laden member upon being wetted by saliva, releases
medicaments that flow from the support structure under the tongue of the
wearer.

[0012] The medicine-laden member for attachment in the support structure
is made in the shape of a cord or string impregnated with a medicament.
The medicine-laden member is made of a string or cord, the material of
the string or cord being polystyrene or other natural or synthetic
material suitable for being impregnated with a medicament. The medicament
impregnated into the cord is releasable when exposed to saliva. The
medicine is released when worn under the tongue region and delivered to
the sublingual area. The types of drugs that may be administered
transmucosally with the device: Insulin and its analogues; Anti-angina
drugs such as the nitrates; Hormones such as the estrogens, androgens and
progestogens; Pain controlling drugs such as the opiates, NSAIDs;
Nicotine replacement drugs; Perhaps even vaccines (these are viral or
bacterial products); and Any drug that needs repeated doses during the
day.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The invention will be described by way of example and with
reference to the accompanying drawings in which:

[0014]FIG. 1A is a first perspective view of the flexible open-support
structure and medicine-laden member of the drug delivery device of the
present invention.

[0015]FIG. 1B is a second perspective view of the flexible open-support
structure and medicine-laden member of FIG. 1A only looking from the open
end of the device.

[0016]FIG. 1c is a cross sectional view of the support structure showing
the two opposing inner and outer bases taken along section lines 1C-1C
from FIG. 1A.

[0017]FIG. 1D is a first perspective view of an alternative embodiment
device of the present invention.

[0018]FIG. 1E is a second view of an alternative embodiment device of the
present invention, looking from above the open ends of the device.

[0019] FIG. 1F is a cross sectional view of an alternative embodiment
device of the present invention.

[0026]FIG. 5B is a cross sectional view of the device similar to FIG. 5A,
but with the inner base and outer base pulled apart allowing both sides
of the support structure to fit over the teeth.

[0027] FIG. 5C is a cross sectional view of an alternative device.

[0028]FIG. 5D is a cross sectional view of the alternative device similar
to FIG. 5C, but with the inner base and outer base pulled apart allowing
both sides of the support structure to fit over the teeth.

[0029] FIG. 6A is a cross sectional view of the device as it appears when
mounted over the front teeth taken along lines 6-6 of FIG. 4.

[0030]FIG. 6B is a cross sectional view of the alternative device as it
appears when mounted over the front teeth.

[0031] FIG. 7A is another cross sectional view taken along lines 7A-7A of
FIG. 4 showing the device has a somewhat more open cavity for fitting on
the molars.

[0032] FIG. 7B is a cross sectional view showing the device's appearance
when open to wear over the rear teeth.

[0033] FIG. 7C is a cross sectional view showing the alternative device's
appearance when open to wear over the rear teeth.

[0034] FIG. 7D is a cross sectional view showing the alternative device's
appearance when open to wear over the rear teeth.

[0035] FIG. 8A is a cross sectional view showing the device mounted over a
large molar tooth in the region of an arch rib taken along lines 8A-8A of
FIG. 4.

[0036] FIG. 8B is the same view as FIG. 8A in an open region between the
arch ribs showing how the device contacts the teeth taken along lines
8B-8B of FIG. 4.

[0037] FIG. 9A is a cross sectional view showing the alternative device
mounted over a large molar tooth in the region of an arch rib.

[0038] FIG. 9B is the same view as FIG. 9A in an open region between the
arch ribs showing how the alternative device contacts the teeth.

[0039] FIG. 10A is a perspective exploded view showing the device with the
support structure and medicine-laden member shown removed therefrom.

[0040]FIG. 10B is a perspective exploded view showing the alternative
device with the support structure and medicine-laden member shown removed
therefrom.

DETAILED DESCRIPTION OF THE INVENTION

[0041] With reference to FIGS. 1A, 1B and 1C; the preferred embodiment
drug delivery device 10 of the present invention is illustrated. As shown
in FIG. 1A, the device 10 has a flexible open-support structure 20. As
shown in FIG. 1c, a medicine-laden member can be affixed to an open
channel or groove 30 of the device 10.

[0042] With reference to FIGS. 1A, 1B and 1C, the flexible open-support
structure 20 is shown in greater detail. The flexible open-support
structure 20 as shown has a pair of opposing bases 22 and 24; these
opposing bases 22, 24 follow a curvature ideally suited to fit over a set
of teeth either upper or lower. Connected to each base 22, 24 is a pair
of arch-shaped ribs 26. The ribs 26 extend outward from the base in an
arch shape and connect to the other base providing a secure spring-like
connection between the two opposing bases 22 and 24. At the top surface
of each arched rib 26 extends a longitudinally extending spine 28. The
optional spine 28 extends along the length of the device in the location
between the arched ribs 26 connecting each arched rib 26. Large open
spaces exist between the arched ribs 26, the spine 28 and bases 22, 24.
As shown, inside each base 22, 24 is an oval channel 29 as illustrated in
FIG. 1A and in greater detail in FIG. 1c. The open channel 29 is composed
of two parts formed by the contour of the inside surface of the base 22,
24 such that when the two opposing faced bases 22, 24 are in contact form
a complete channel 29 as illustrated. The channel 29 flexes when placed
in the mouth and fitted in place over the teeth creating a gripping or
suction action to help hold the device 10 on the teeth and gums.

[0043] As shown in FIG. 1B from the ends of the bases, one can easily
appreciate that the device 10 is held in a spring-like fashion wherein
the channel 29 is maintained closed until the bases 22, 24 are separated
apart.

[0044] On each side of the inner and outer bases at the bottom of the
device 10 are a pair of feet 25. The feet 25 provide a flat surface and
facilitate holding the device when placing it in the mouth.

[0045] As further shown in FIG. 1B, the ends of the device 10 are clearly
visibly showing the medicine-laden member 100 affixed to the inner base
22 along an exterior surface. As better illustrated in FIG. 1c shown in a
cross sectional view the medicine-laden member 100 is shown affixed in a
groove 30. The groove 30 as shown is of circular cross section and
extends along the length of the inner base 22. The opening of the groove
30 is large enough to accept the member 100 by flexing open as the member
100 is pressed into the groove 30. This enables the groove 30 at each end
to grip onto the member preventing it from dislodging in the mouth when
used by the wearer of the device 10.

[0046] With reference to FIGS. 1D, 1E and 1F; an alternative embodiment
device 10 is illustrated. The alternative embodiment device 10 is
identical to the preferred embodiment device shown in FIGS. 1A, 1B and 1C
except that the groove 30 has been replaced by a flange 27 extending from
the foot 25 along the inner base 22. The flange 27 and the inner base 22
form a groove or channel 32 into which the medicine-laden member 100 can
be affixed. At an end of the flange 27 an enlarged projection 33 is
shown. When placing a medicine-laden member 100 into the groove 32 the
flange 27 flexes outwardly until the member 100 fully enters the channel
or groove 32 wherein the flange 27 and projection 33 firmly hold the
member 100 in place preventing it from dislodging. The reference numerals
for the elements of both the preferred embodiment device 10 and the
alternative device 10 are the same except for those features associated
with securing the member 100. For illustrative purposes both embodiments
are shown in FIGS. 5A-10B. In FIG. 4 only the preferred embodiment device
is shown, it being understood the alternative device 10 fits over the
teeth in an identical manner.

[0047] In FIGS. 2A and 3 an end view of a bottom row of teeth 2 and a top
view looking down on the bottom row of teeth 2 are shown respectively. In
FIGS. 2B and 4 the device 10 is shown mounted on the teeth 2.

[0048] In FIGS. 5A and 5B the preferred device 10 is shown in a cross
section and in FIGS. 5C and 5D the same views of the alternative device
are shown. These views depict how the inner base 22 and outer base 24 are
expanded to fit onto the teeth 2.

[0049] In the cross sectional views of FIGS. 6A, 6B, 7A, 7B, 7C, 7D, 8A,
8B, 9A and 9B, the devices 10 of the preferred and alternative embodiment
are shown with the medicine 101 being dispensed from the member 100. In
FIG. 6A, the front portion of the device 10 is illustrated fitting over
the front teeth 2 which are substantially narrower than the
rearward-positioned molars. The teeth 2 and the device 10 extend down to
the gums 4 providing a fit over the teeth 2 and along the gums 4 in this
area. In FIGS. 7A-7D the teeth 2 are not shown. With reference to FIGS.
8A, 8B, 9A and 9B, showing the rear portion of the devices 10 when the
bases 22, 24 are spread apart in such a fashion that the devices 10 can
fit over the shallower molars 2 which are substantially wider, therefore
creating a more open appearance of the devices 10. Again the devices 10
fit directly over the teeth 2 and along the gums 4 as illustrated. In
this case, medicine 101 is shown as a dispersion spreading the medicine
101 downward past the gums 4 as the saliva activates release of the
medicine 101 allowing it to migrate along the gums 4 and into a mucous
membrane area under the tongue, (the tongue is not shown, to expose the
mucous membrane area).

[0050] With reference to FIGS. 10A and 10B, the device 10 of the preferred
and alternative embodiments is shown in exploded view. The medicine-laden
member 10 being removed from the support structure 20. With particular
reference to the medicine-laden member 100 it is shown formed as a string
or cord 102 laden with medicine 101. The medicine-laden member 100 for
attachment in the support structure 20 is made in the shape of a cord or
string 102 impregnated with a medicament 101. The medicine-laden member
100 is made of a string or cord 102, the material of the string or cord
being polystyrene or other natural or synthetic material suitable for
being impregnated with a medicament 101. The medicament 101 impregnated
into the cord 102 is releasable when exposed to saliva. The medicine 101
is released when worn under the tongue region and delivered to the
sublingual membrane. The types of drugs 101 that may be administered
transmucosally with the device: Insulin and its analogues; Anti-angina
drugs such as the nitrates; Hormones such as the estrogens, androgens and
progestogens; Pain controlling drugs such as the opiates, NSAIDs;
Nicotine replacement drugs; Perhaps even vaccines (these are viral or
bacterial products); and Any drug that needs repeated doses during the
day. It is important to note the member 100 can be impregnated with more
than one drug or medicament 101 in a combination. For example, an
antihistamine and a decongestant or a blood pressure lowering medicine
along with a cholesterol lowering drug could be combined. For that
matter, the member 100 could be pharmaceutically prepared to match a
specific patient by having a specific combination of prescribed medicines
impregnated for a specific patient. In this manner, the patient simply
wears the device and all required medicines can be delivered in a
controlled manner without requiring multiple administrations of oral or
injectables. This greatly simplifies the procedure and insures proper
dosages and medicines are taken. One way to achieve multiple medicines is
to have the member 100 comprised of two or more cords or threads 102 each
having different medicaments 101 so these different drugs can be
administered at the same time.

[0051] As illustrated, this device 10 is designed to be worn any time. It
can be worn over a period of several hours due to the pliant nature of
the open support structure 20. The device 10 is adapted to be minimally
invasive and of such light weight that the wearer can wear it comfortably
without hampering his or her ability to eat or talk. As shown, the device
10 is mounted preferably on the lower set or row of teeth 2. As shown,
the device 10 provides an excellent means for providing prolonged
treatment with otherwise injectable or erratically absorbed medicines.
This is of particular value in that most medicaments cannot currently be
provided or applied over a period of time. The present invention provides
an ideal means for providing the medicaments over an extended period of
time. This is particularly important as it makes it possible for the
wearer to get an extended treatment heretofore unavailable. This feature
is particularly useful when treating chronic conditions such as diabetes
with insulin. Antibiotics and other medicines can be used with this
device 10 which can make the treatment shorter in overall duration and
more effective, possibly eliminating the need to administer the
antibiotics systemically by way of pills taken orally or injections. The
present invention, as designed is molded to the shape of the open support
structure 20.

[0052] Variations in the present invention are possible in light of the
description of it provided herein. While certain representative
embodiments and details have been shown for the purpose of illustrating
the subject invention, it will be apparent to those skilled in this art
that various changes and modifications can be made therein without
departing from the scope of the subject invention. It is, therefore, to
be understood that changes can be made in the particular embodiments
described, which will be within the full intended scope of the invention
as defined by the following appended claims.